Elan Corporation, plc and Transition Therapeutics Inc in a phase II study have begun dosing of ELND005 (AZD-103) in patients with Alzheimer's disease.
The study will evaluate both cognitive and functional endpoints, and each patient's participation is planned to last approximately 18 months, the company said in a recent press release.
The randomised, double-blind, placebo-controlled, dose-ranging, safety and efficacy study would examine approximately 340 patients with mild to moderate Alzheimer's disease. Approximately 65 sites in North America are expected to participate in the programme.
ELND005 is an orally-administered therapeutic agent that has received fast track designation from the US Food and Drug Administration (FDA) for treatment of mild to moderate Alzheimer's disease. Fast track designation facilitates development and may expedite regulatory review of drugs that the FDA recognizes as potentially addressing an unmet medical need for serious or life-threatening conditions.
In multiple phase II studies that evaluated the safety, tolerability and pharmacokinetic profile of ELND005 in approximately 110 healthy volunteers, ELND005 was safe and well-tolerated at all doses and dosing regimens examined. No severe or serious adverse events were observed. Preclinical data suggest that ELND005 may act through the unique mechanism of preventing and reversing the fibrilisation of beta-amyloid, a toxic peptide that forms plaques that are a key pathological feature of Alzheimer's disease.
Alzheimer's disease, a leading cause of dementia, is a progressive brain disorder that gradually destroys a person's memory and ability to learn, reason, make judgments, communicate and carry out daily activities. Alzheimer's disease may result from the build-up of toxic beta-amyloid peptides in the brain. As Alzheimer's disease progresses, individuals may also experience changes in personality and behaviour, such as anxiety, suspiciousness or agitation, as well as delusions or hallucinations. It is currently estimated that more than 5 million Americans have Alzheimer's disease and more than 24 million people worldwide over the age of 60 have some form of dementia.
Elan Corporation, plc is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world.
Transition is a biopharmaceutical company, developing novel therapeutics for disease indications with large markets. Transition's lead products include ELND005/ AZD-103 for the treatment of Alzheimer's disease and TT-223 for the treatment of diabetes. Transition has an emerging pipeline of preclinical drug candidates acquired externally or developed internally using its proprietary drug discovery engine.